Priority Substances List Assessment Report for Butylbenzylphthalate

1.0 Introduction

The Canadian Environmental Protection Act (CEPA) requires the federal Ministers of Environment and of Health to prepare and publish a Priority Substances List (PSL) that identifies substances, including chemicals, groups of chemicals, effluents and wastes, that may be harmful to the environment or constitute a danger to human health. The Act also requires both Ministers to assess these substances and determine whether they are "toxic" as defined in Section 11 of the Act, which states:

... a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions

1. having or that may have an immediate or long-term harmful effect on the environment;
2. constituting or that may constitute a danger to the environment on which human life depends; or
3. constituting or that may constitute a danger in Canada to human life or health.

Substances that are assessed as "toxic" as defined in Section 11 may be placed on Schedule I of the Act and considered for possible risk management measures, such as regulations, guidelines or codes of practice to control any aspect of their life cycle, from the research and development stage through manufacture, use, storage, transport and ultimate disposal.

Based on initial screening of readily accessible information, the rationale for assessing butylbenzylphthalate (BBP) provided by the Ministers' Expert Advisory Panel on the Second Priority Substances List (Ministers' Expert Advisory Panel, 1995) was as follows:

There is considerable potential for human exposure to BBP. It is used in a wide range of consumer products including floor coverings, hairsprays, pesticides, colourants, insect repellents and perfumes. BBP has been detected in Canadian aquatic systems and biota, soils, foods, tap water and indoor air. BBP is bioaccumulative, and toxicological studies show that it may cause adverse effects in humans and other organisms. There are also concerns that this substance may interfere with endocrine function. An assessment is needed to determine the extent of exposure and associated risks.

Descriptions of the approaches to assessment of the effects of Priority Substances on the environment and human health are available in published companion documents. A document entitled "Environmental Assessments of Priority Substances under the Canadian Environmental Protection Act. Guidance Manual Version 1.0 -March 1997" (Environment Canada, 1997a) provides guidance for conducting environmental assessments of Priority Substances in Canada. This document may be purchased from:

Environmental Protection Publications
Environmental Technology Advancement Directorate
Environment Canada
Ottawa, Ontario
K1A 0H3

It is also available on the Internet at www.ec.gc.ca/cceb1/eng/psap.htm under the heading "Technical Guidance Manual."

The approach to the assessment of effects on human health is outlined in the following publication of the Environmental Health Directorate of Health Canada: "Canadian Environmental Protection Act - Human Health Risk Assessment for Priority Substances" (Health Canada, 1994), copies of which are available from:

Environmental Health Centre
Room 104
Health Canada
Tunney's Pasture
Ottawa, Ontario
K1A 0L2

or on the Environmental Health Directorate publications web site (www.hc-sc.gc.ca/ehp/ehd/ catalogue/bch.htm). The approach is also described in an article published in the Journal of Environmental Science and Health - Environmental Carcinogenesis & Ecotoxicology Reviews (Meek et al., 1994). It should be noted that the approach outlined therein has evolved to incorporate recent developments in risk assessment methodology, which are described on the Environmental Substances Division web site (www.hc-sc.gc.ca/ehp/ehd/bch/env_ contaminants/psap/psap.htm) and which will be addressed in future releases of the approach paper for the assessment of effects on human health.

The search strategies employed in the identification of data relevant to the assessment of potential effects on the environment (prior to May 1998) and human health (prior to April 1998) are presented in Appendix A. Review articles were consulted where appropriate. However, all original studies that form the basis for determining whether BBP is "toxic" under CEPA have been critically evaluated by staff of Environment Canada (entry and environmental exposure and effects) and Health Canada (human exposure and effects on human health).

The environmental sections of this Assessment Report and the supporting documentation (Environment Canada, 1998) were produced by K. Taylor, Environment Canada, and reviewed by members of the Environmental Resource Group, established by Environment Canada to support the environmental assessment of BBP:

E. Brien, Environment Canada

B.K. Burnison, National Water Research Institute, Environment Canada

G. Coyle, Solutia Inc.

J. Headley, National Water Research Institute, Environment Canada

T. Parkerton, Exxon Biomedical Sciences Inc.

J. Prinsen, Environment Canada

A. Sardella, Solutia Inc.

N. Tremblay, Environment Canada

The health-related sections of this Assessment Report and the supporting documentation were prepared by the following staff of Health Canada:

G. Long

M.E. Meek

Sections of the Assessment Report and the supporting documentation on genotoxicity and reproductive and developmental toxicity were reviewed by D. Blakey and W. Foster, respectively, of the Environmental and Occupational Toxicology Division of Health Canada.

Sections of the supporting documentation pertaining to human health were reviewed externally by R. Nair, Solutia Inc., primarily to address adequacy of coverage. Accuracy of reporting, adequacy of coverage and defensibility of conclusions with respect to hazard characterization and dose-response analyses were considered in a written review by staff of the Information Department of BIBRA International and at a panel meeting of the following members, convened by Toxicology Excellence for Risk Assessment (TERA) on April 27, 1998, in Cincinnati, Ohio:

M. Abdel-Rahman, University of Medicine & Dentistry of New Jersey

J. Christopher, California Environmental Protection Agency

G. Datson, The Procter & Gamble Company

J. Donohue, U.S. Environmental Protection Agency

M. Dourson, TERA

D. Proctor, ChemRisk

R. Rudel, Silent Spring Institute (submitted written comments; not able to attend panel meeting)

A. Stern, New Jersey Department of Environmental Protection

A Concise International Chemical Assessment Document (CICAD), which was prepared on the basis of the content of this Assessment Report, was also externally reviewed by:

R.A. Andersen, Norwegian University of Science and Technology, Norway

T. Berzins, National Chemicals Inspectorate, Sweden

R. Cary, Health and Safety Executive, United Kingdom

R. Chapin, National Institute of Environmental Health Sciences, USA

R.S. Chhabra, National Institute of Environmental Health Sciences, USA

J. DeFouw, RIVM, The Netherlands

R.J. Fielder, Department of Health, United Kingdom

P. Foster, Chemical Industry Institute of Toxicology, USA

S. Jordan, Food Directorate, Health Canada

P. Lundberg, National Institute for Working Life, Sweden

C. Nilsson, Institute of Environmental Medicine, Sweden

P. Ridgeway, Health and Safety Executive, United Kingdom

E. Soderlund, National Institute of Public Health, Norway

F.M. Sullivan, consultant Toxicologist,United Kingdom

K. Svensson, National Food Administration, Sweden

S. Tarkowski, Nofer Institute of Occupational Medicine, Poland

J. Taylor, Agency for Toxic Substances and Disease Registry, USA

G. Ungvary, Jozsef Fodor National Centre of Public Health, Hungary

A. Wibbertmann, Fraunhofer Institute for Toxicology and Aerosol Research, Germany

Subsequently, a revised version of the CICAD was approved at a meeting in Tokyo, Japan, on June 30 - July 2, 1998, by a Final Review Board composed of:

R. Benson, Environmental Protection Agency, USA

T. Berzins, National Chemicals Inspectorate, Sweden

R. Cary, Health and Safety Executive, United Kingdom

C. DeRosa, Agency for Toxic Substances and Disease Registry, USA

S. Dobson, Institute of Terrestrial Ecology, United Kingdom

H. Gibb, Environmental Protection Agency, USA

R.F. Hertel, Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany

I. Mangelsdorf, Fraunhofer Institute for Toxicology and Aerosol Research, Germany

M.E. Meek, Health Canada, Canada

J. Sekizawa, National Institute of Health Sciences, Japan

S.A. Soliman, Alexandria University, Egypt

D. Willcocks, Worksafe Australia, Australia

P. Yao, Chinese Academy of Preventative Medicine, People's Republic of China

The health-related sections of the Assessment Report were reviewed and approved by the Health Protection Branch Risk Management meeting of Health Canada.

The entire Assessment Report was reviewed and approved by the Environment Canada/Health Canada CEPA Management Committee.

A draft of the Assessment Report was made available for a 60-day public comment period (May 1 to June 29, 1999) (Environment Canada and Health Canada, 1999). Following consideration of comments received, the Assessment Report was revised as appropriate. A summary of the comments and their responses is available on the Internet at:

www.ec.gc.ca/cceb1/eng/f inal/index_e.html

The text of the Assessment Report has been structured to address environmental effects initially (relevant to determination of "toxic" under Paragraphs 11(a) and (b)), followed by effects on human health (relevant to determination of "toxic" under Paragraph 11(c)).

Copies of this Assessment Report are available upon request from:

Inquiry Centre
Environment Canada
Main Floor, Place Vincent Massey
351 St. Joseph Blvd.
Hull, Quebec
K1 A 0H3

or on the Internet at:

www.ec.gc.ca/cceb1/eng/f inal/index_e.html

Unpublished supporting documentation, which presents additional information, is available upon request from:

Commercial Chemicals Evaluation Branch
Environment Canada
14th Floor, Place Vincent Massey
351 St. Joseph Blvd.
Hull, Quebec
K1A 0H3

or

Environmental Health Centre
Room 104 Health Canada
Tunney's Pasture
Ottawa, Ontario
K1A 0L2